Registry and biobank for ocular complications from cancer therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to collect data from patients at the University of Maryland who have undergone cancer therapy, focusing on those at risk for ocular complications such as graft versus host disease (GVHD) and inflammatory dry eye disease. Participants will undergo standard eye examinations, and biological specimens will be collected for analysis to gain insights into the immunologic and cellular mechanisms behind these ocular issues. The study will create a registry and biobank to better understand the pathogenesis of ocular toxicity and identify predictive factors for developing complications post-cancer therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria for the Cancer Therapy Group:

* Adult patients (greater than 18 years of age)
* Deny a history of eye diseases (excluding cataract, glaucoma, mild dry eye disease, or history of cataract or refractive surgery)
* Patients who have a history of allogenic HSCT with all stem cell sources including bone marrow, PBSC, cord AND/OR patients with a history of prior cancer therapy including BMT, chemotherapy, and immunotherapy
* Patients will be recruited after their HSCT or cancer therapy at their ophthalmology appointment
* Patients can be included with a history of prior cancer therapy including chemotherapy, BMT, immunotherapy. Prior cancer therapy must be identified and documented.
* The patient must be able to understand and sign and date the informed consent form approved by the IRB.

Inclusion Criteria for the Control Group:

* No history of cancer or cancer therapy in the past
* Adult patients (greater than 18 years of age)
* Deny a history of eye diseases (excluding cataract, glaucoma, mild dry eye disease, or history of cataract or refractive surgery)
* The patient must be able to understand and sign and date the informed consent form approved by the IRB.

Exclusion Criteria for the Cancer Therapy Group:

* Vulnerable populations: neonates, children, prisoners, institutionalized individuals
* Inability or refusal to provide informed consent.
* History of ocular surgery or ocular disease (except refractive or cataract surgery, mild dry eye disease, or glaucoma).

Exclusion Criteria for the Control Group:

* Vulnerable populations: neonates, children, prisoners, institutionalized individuals
* Inability or refusal to provide informed consent.
* History of ocular surgery or ocular disease (except refractive or cataract surgery, mild dry eye disease, or glaucoma).
* History of cancer or cancer therapy including chemotherapy, immunotherapy, BMT.

Where it's running

• Stoler Outpatient Cancer Center at the University of Maryland
  Baltimore, Maryland, United States Recruiting

Study contacts

• Study coordinator: Sarah Sunshine, MD
• Email: ssunshine@som.umaryland.edu
• Phone: 667-214-1292

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.